www.fdanews.com/articles/170671-mylan-recalls-two-injectable-drugs-made-in-india
Mylan Recalls Two Injectable Drugs Made in India
April 7, 2015
Mylan is recalling two injectables — a hypertension drug and cancer treatment — due to quality control issues. Both drugs were manufactured in India.
On Jan. 23, the drugmaker recalled 78,090 vials of nicardipine hydrochloride injection, 25 mg/10 ml, due to potential subpotency and failed specifications for impurities and degradation.
The recall, cited in a recent FDA enforcement report, involves single dose vials of the blood pressure medication.
Mylan initiated a second recall on Feb. 11 of 936 vials of cancer treatment doxorubicin hydrochloride injection because ifosfamide injection may have been mispackaged in a carton labeled with the drug. — Jonathon Shacat